Label: ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 10, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Alka-Seltzer Plus® Severe Cold PowerFast Fizz Day Effervescent Tablets

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purposes

    Aspirin 325 mg (NSAID)*…….………………………..Pain reliever/fever reducer

    Dextromethorphan hydrobromide 10 mg……………………Cough suppressant

    Phenylephrine bitartrate 7.8 mg.......……....…....…………..Nasal decongestant

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms due to a cold with cough:
      • minor aches and pains
      • headache
      • sinus congestion and pressure
      • cough
      • sore throat
      • nasal congestion
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a

    doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    · hives · facial swelling · asthma (wheezing) · shock

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    ● are age 60 or older

    ● have had stomach ulcers or bleeding problems

    ● take a blood thinning (anticoagulant) or steroid drug

    ● take other drugs containing prescription or nonprescription NSAIDs

    (aspirin, ibuprofen, naproxen, or others)

    ● have 3 or more alcoholic drinks every day while using this product

    ● take more or for a longer time than directed

    Sore throat warning: If sore throat is severe, persists for more than 2 days,

    is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use

    ● if you are allergic to aspirin or any other pain reliever/fever reducer

    ● if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

    ● if you have ever had an allergic reaction to this product or any of itsingredients

    ● in children under 12 years of age

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have
      • asthma •thyroid •disease diabetes
      • cough that occurs with excessive phlegm (mucus)
      • difficulty in urination due to enlargement of the prostate gland
      • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
      • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for
      • gout
      • diabetes
      • arthritis

    When using this product do not exceed recommended dosage.

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • pain, cough, or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • cough comes back or occurs with rash or headache that lasts. These
    • could be signs of a serious condition.
    • nervousness, dizziness, or sleeplessness occurs

    If pregnant or breast-feeding, ask a health professional before use.

    It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than the recommended dose
    • do not take the Day and Night products at the same time; wait 4 hours after taking the last Night dose before taking the Day product
    • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
    • children under 12 years: do not use
  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains: potassium 78 mg; sodium 356 mg
    • store at room temperature. Avoid excessive heat.
  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, FD&C red #40, FD&C yellow #6, flavor, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

  • QUESTIONS

    Questions or comments? 1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

  • SPL UNCLASSIFIED SECTION

    Alka-Seltzer Plus® Cold PowerFast Fizz Night Effervescent Tablets

  • ACTIVE INGREDIENT

    Active ingredients (in each tablet) Purposes

    Aspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducer

    Dextromethorphan hydrobromide 10 mg……..…..……Cough suppressant

    Doxylamine succinate 6.25 mg………………..…..………...…Antihistamine

    Phenylephrine bitartrate 7.8 mg.......…………..…...….Nasal decongestant

    *nonsteroidal anti-inflammatory drug

  • PURPOSE

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves these symptoms due to a cold:
      • minor aches and pains
      • headache
      • runny nose
      • sinus congestion and pressure
      • cough
      • sneezing
      • sore throat
      • nasal congestion
    • temporarily reduces fever
  • WARNINGS

    Warnings

    Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

    Allergy alert: Aspirin may cause a severe allergic reaction which may include:

    • hives
    • facial swelling ·
    • asthma (wheezing)
    • shock

    Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

    • are age 60 or older
    • have had stomach ulcers or bleeding problems
    • artake a blood thinning (anticoagulant) or steroid drug
    • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
    • have 3 or more alcoholic drinks every day while using this product
    • take more or for a longer time than directed

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

    Do not use to sedate children.

    Do not use

    • if you are allergic to aspirin or any other pain reliever/fever reducer
    • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
    • if you have ever had an allergic reaction to this product or any of its ingredients
    • in children under 12 years of age

    Ask a doctor before use if

    • stomach bleeding warning applies to you
    • you have a history of stomach problems, such as heartburn
    • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
    • you are taking a diuretic
    • you have
      • asthma
      • diabetes
      • thyroid disease
    • glaucoma
    • cough that occurs with excessive phlegm (mucus)
    • a breathing problem such as emphysema or chronic bronchitis
    • difficulty in urination due to enlargement of the prostate gland
    • persistent or chronic cough such as occurs with smoking, asthma,or emphysema
    • a sodium-restricted diet

    Ask a doctor or pharmacist before use if you are

    • taking a prescription drug for
      • gout
      • diabetes
      • arthritis
    • taking sedatives or tranquilizers

    When using this product

    • do not exceed recommended dosage
    • may cause marked drowsiness
    • avoid alcoholic drinks
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • be careful when driving a motor vehicle or operating machinery
    • excitability may occur, especially in children

    Stop use and ask a doctor if

    • an allergic reaction occurs. Seek medical help right away.
    • you experience any of the following signs of stomach bleeding
      • feel faint
      • vomit blood
      • have bloody or black stools
      • have stomach pain that does not get better
    • pain, cough, or nasal congestion gets worse or lasts more than 7 days
    • fever gets worse or lasts more than 3 days
    • redness or swelling is present
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • cough comes back or occurs with rash or headache that lasts. These
    • could be signs of a serious condition.
    • nervousness, dizziness, or sleeplessness occurs

    If pregnant or breast-feeding, ask a health professional before use.
    It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • do not take more than the recommended dose
    • do not take the Day and Night products at the same time; wait 4 hours after taking the last Day dose before taking the Night product
    • adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 4 tablets in 12 hours or as directed by a doctor.
    • children under 12 years: do not use
  • OTHER SAFETY INFORMATION

    Other information

    • each tablet contains: potassium 78 mg; sodium 356 mg
    • store at room temperature. Avoid excessive heat.

  • INACTIVE INGREDIENT

    Inactive ingredients anhydrous citric acid, calcium silicate, dimethicone, flavors, mannitol, potassium bicarbonate, povidone, sodium bicarbonate, sucralose

  • QUESTIONS

    Questions or comments? 1-800-986-0369 (Mon-

    Fri 9AM – 5PM EST)

  • PRINCIPAL DISPLAY PANEL

    Alka-Seltzer Plus®

    SEVERE COLD

    DAY/CITRUS

    NIGHT LEMON

    POWERFAST FIZZ™

    DAY NON-DROWSY

    ASPIRIN (NSAID)/Pain Reliever - Fever Reducer

    DEXTROMETHORPHAN HBr/Cough Suppressant

    PHENYLEPHRINE BITARTRATE/Nasal Decongestant

    • Nasal Decongestant
    • Headache + Body Ache
    • Cough
    • Sore Throat
    • Sinus Pressure

    12 EFFERVESCENT TABLETS

    NEW NIGHT DOSING DIRECTIONS

    NIGHT

    Aspirin (NSAID)/Pain Reliever-Fever Reducer

    Dextromethorphan HBr/Cough Suppressant

    Doxylamine Succinate/Antihistamine

    Phenylephrine Bitartrate/Nasal Decongestant

    • Nasal congestion
    • Headache + Body Ache
    • Cough
    • Runny Nose
    • Sore Throat

    8 EFFERVESCENT TABLETS

    Carton 20 count

  • INGREDIENTS AND APPEARANCE
    ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY AND NIGHT 
    aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0069
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0280-0069-011 in 1 CARTON; Type 0: Not a Combination Product08/05/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 112 POUCH 12 
    Part 28 POUCH
    Part 1 of 2
    ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY 
    aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    MANNITOL (UNII: 3OWL53L36A)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    POVIDONE (UNII: FZ989GH94E)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorORANGEImprint Code ASP;DAY
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/05/2021
    Part 2 of 2
    ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NIGHT 
    aspirin, doxylamine succinate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescent
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
    DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
    Inactive Ingredients
    Ingredient NameStrength
    MANNITOL (UNII: 3OWL53L36A)  
    POVIDONE (UNII: FZ989GH94E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize25mm
    FlavorLEMON, ORANGEImprint Code ASP;NT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/05/2021
    Labeler - Bayer HealthCare LLC. (112117283)